NCT06313008 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Naing S, Poliyedath A, Khandelwal S, Sigala T
Impact of EMPA-REG OUTCOME(R) on the management of type 2 diabetes mellitus: a review for primary care physicians. Postgrad Med. 2016 Nov;128(8):822-827. doi: 10.1080/00325481.2016.1245093. Epub 2016 Oct 25.
Schernthaner G, Schernthaner-Reiter MH, Schernthaner GH
EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus. Clin Ther. 2016 Jun;38(6):1288-1298. doi: 10.1016/j.clinthera.2016.04.037. Epub 2016 May 19.
Shimizu W, Kubota Y, Hoshika Y, Mozawa K, Tara S, Tokita Y, Yodogawa K, Iwasaki YK, Yamamoto T, Takano H, Tsukada Y, Asai K, Miyamoto M, Miyauchi Y, Kodani E, Ishikawa M, Maruyama M, Ogano M, Tanabe J; EMBODY trial investigators
Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial. Cardiovasc Diabetol. 2020 Sep 25;19(1):148. doi: 10.1186/s12933-020-01127-z.
Tanaka A, Shimabukuro M, Okada Y, Taguchi I, Yamaoka-Tojo M, Tomiyama H, Teragawa H, Sugiyama S, Yoshida H, Sato Y, Kawaguchi A, Ikehara Y, Machii N, Maruhashi T, Shima KR, Takamura T, Matsuzawa Y, Kimura K, Sakuma M, Oyama JI, Inoue T, Higashi Y, Ueda S, Node K; EMBLEM Trial Investigators
Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial. Cardiovasc Diabetol. 2017 Apr 12;16(1):48. doi: 10.1186/s12933-017-0532-8.

A Clinical Study Comparing Effects of Empagliflozin Versus Vildagliptin on Inflammatory Biomarkers, and Atrial Function in Coronary Artery Disease Patients With Type 2 Diabetes: EMBA-VILDA-Response Trial.

Details for clinical trial NCT06313008

Clinical trial NCT06313008 - References